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FDA Warns of Potential Long-Term Risks Of Clarithromycin in Patients with Heart Disease

FDA recommends that health care providers practice caution before prescribing clarithromycin to patients with heart disease due to potentially fatal long-term risks.

The US Food and Drug Administration (FDA) has released a Safety Announcement regarding the antibiotic clarithromycin, known as Biaxin.

Data yielded from a recent study has prompted the FDA to advise that providers practice caution before choosing to prescribe the antibiotic for those with heart disease, as the antibiotic could potentially put these individuals at increased risk for heart problems or death in later years.

“Our recommendation is based on our review of the results of a 10-year follow-up study of patients with coronary heart disease from a large clinical trial that first observed this safety issue,” the announcement reads.

The large clinical trial referred to as CLARICOR, found “an unexpected increase in deaths among patients with coronary heart disease” who had been given a 2-week course of the antibiotic; the increase in deaths became apparent after the patients were followed for 1 year or longer, according to the FDA. However, researchers have been unable to pinpoint an exact explanation for this. The FDA notes that other observational studies have also noted an increase in deaths as well as other serious heart-related problems, while others have not.

“Of the 6 observational studies published to date in patients with or without coronary artery disease, 2 found evidence of long-term risks for clarithromycin, and 4 did not,” the announcement reads.

These findings have also led the FDA to add a new warning regarding the increased risk of potential death in this patient population; due to the potentially fatal long-term risks, the FDA advises that prescribers consider the use of other antibiotics in these patients. The study results have been added to clarithromycin drug labels as well.

Clarithromycin is used for a wide variety of mild-to-moderate bacterial infections, according to the National Institute of Health’s PubChem Open Chemistry Database; these infections include pneumonia, pharyngitis, acute sinus infections, and other infections caused by bacteria. In addition, the antibiotic can also be used “off-label” to treat opportunistic infections of HIV, according to the NIH.

This is not the first time that the FDA has called attention to this safety issue; they also released an announcement regarding similar concerns in December 2005, previous to the 10-year follow-up results yielded by CLARICOR.

“Health care providers should be aware of these significant risks and weigh the benefits and risks of clarithromycin before prescribing it to any patient, particularly in patients with heart disease and even for short periods, and consider using other available antibiotics,” the FDA recommends. “Advise patients with heart disease of the signs and symptoms of cardiovascular problems, regardless of the medical condition for which you are treating them with clarithromycin.”

Providers should report any clarithromycin-associated side effects to the FDA MedWatch program.